More than 30 million Americans are exposed to hazardous sound levels on a regular basis. Of the 28 million Americans who have significant hearing loss, about one-third can be attributed, in part, to noise exposure. Availability of an effective treatment that prevents hearing loss in at-risk human populations would improve the quality of life for millions, and decrease healthcare costs for individuals, businesses, and government agencies. OtoMedicine Inc. has identified a proprietary combination of dietary supplements called AuraQuell", which is highly effective in preventing permanent noise-induced hearing loss (NIHL) and sensory cell death in a guinea pig model. Research conducted during the Phase I SBIR demonstrated that AuraQuell" was also effective at reducing temporary hearing loss in the guinea pig. This is highly relevant, because for practical and ethical reasons clinical testing of the efficacy of AuraQuell" in humans will initially be conducted in subjects exposed to loud noise producing temporary NIHL. This Phase II SBIR will first establish a paradigm to reliably produce a temporary threshold shift (TTS) in subjects exposed to loud, but safe video-game shooting noise. The goal is to produce approximately a 10-15 decibel temporary hearing loss, which is sufficient to power a clinical trial. Once established, a double-blind, placebo-controlled clinical trial will be conducted in 120 subjects to establish the efficacy of AuraQuell" to prevent TTS (temporary hearing loss). Gunfire noise was chosen because it is relevant to significant markets including the military and hunters. Data generated by this SBIR is critical to the successful commercialization of AuraQuell". In Phase III, OtoMedicine will petition the FDA's Center for Food Safety and Applied Nutrition (as specified in 21CFR 101.70) for a health claim and market AuraQuell" as a safe and efficacious preventative treatment for NIHL. PUBLIC HEALTH RELEVANCE: Approximately 28 million Americans have some degree of hearing loss;approximately one-third of which is the result of exposure to loud noise. This proposal will test a safe product that could be an effective treatment that reduces noise-induced hearing loss in at-risk human populations. This would improve the quality of life for millions, and decrease healthcare costs for individuals, businesses, and the military.